Nickel Allergic Contact Dermatitis

October 22, 2015

Introduction

Nickel allergic contact dermatitis (NACD) is a well-known skin condition which can be acquired after direct and prolonged contact with items which release a sufficient amount of nickel. Nickel release, not nickel content, is the most important factor in determining if an article will cause people to become allergic to nickel or cause NACD in nickel-allergic people.

Position statement on Piercing Materials

Nickel Institute and NiPERA support using appropriate materials in appropriate applications for many reasons, including avoidance of adverse health effects. If the use involves direct and prolonged contact with the skin, including body piercings, then only appropriate materials should be used to avoid nickel allergic contact dermatitis. In some individuals an allergic reaction may occur if an article is in direct and prolonged contact when three conditions are present: 1) the nickel in the material must be corroded, 2) the resulting nickel compounds must be solubilized, and 3) the nickel ions must be absorbed by the skin to cause a reaction.

The European standard EN1811 measures the potential amount of nickel release under the conditions of direct and prolonged contact with the skin. Articles such as those used for earrings in children should not release more than 0,2 µg Ni/cm²/week (by EN1811 testing) to prevent children from becoming allergic to nickel or having a dermatitis reaction if they are already allergic to nickel. This nickel release rate is from parts of earrings that are in contact with the skin and within the pierced part of the ear.

Because it is the rate of release of nickel (and not nickel content itself) that is important and relevant in determining whether there is a risk for nickel allergic contact dermatitis, articles may contain nickel but not cause a dermatitis reaction. For example, 'surgical' stainless steel (SS 316L), which contains 10-15% nickel and does not release nickel more than 0,2µg Ni/cm²/week (using EN1811 test), is therefore regarded as appropriate for use in articles in direct and prolonged contact with the skin. The ASTM Standard Consumer Safety Specification for Adult Jewelry (Designation: F2999-13) lists surgical stainless steel (typically containing 10-15% nickel) as one of the 'Approved Materials for Adult Body-Piercing Jewerly'.

NACD Stakeholder workshops

27 June 2017 - Brussels

On 27 June, the Nickel Institute hosted its third stakeholder workshop on nickel allergy. The event "Nickel allergy and the EU nickel restriction – articles in direct and prolonged contact with the skin: state of play and challenges ahead" brought together dermatologists, regulators, testing and standardisation experts as well as industry, to discuss the latest EU activities on the implementation of the nickel restriction in “articles in prolonged and direct skin contact”.

The aim of the workshop was:

- To provide an update on the latest EU activities relevant to the implementation of the nickel restriction: draft ECHA Guidelines on “prolonged skin contact”, ongoing sources of nickel allergy, testing developments, etc.
- To openly discuss with stakeholders their practical experiences, challenges, concerns and expectations vis-à-vis the implementation of the EU nickel restriction, current developments and potential implications;
- To better understand existing science relevant to the nickel restriction and review additional scientific information relevant to nickel dermatitis;
- To inform stakeholders on the results of the Nickel Institute’s scientific research project on “prolonged skin contact”.

Download the summary report.Presentations and further information can be found here.

23 June 2016 - Chicago

The workshop provided a timely opportunity for interested parties to share their views and experiences as well as their concerns and expectations regarding communication and prevention strategies to decrease prevalence of nickel dermatitis in North America.

The participants were provided with a complete overview of all dimensions around the issue of nickel allergic contact dermatitis, including history of prevalence, the science, challenges, and next steps. The workshop also informed about the many beneficial properties of nickel and nickel-containing materials and their vital role in a wide range of applications.

Download the summary report. Presentations and further information can be found here.

25 June 2015 - Brussels

The Nickel Institute hosted a workshop in June 2015 which brought together over 50 stakeholders, including representatives from EU institutions, national authorities, dermatologists, industry, standards authorities and testing experts. The event provided participants with a neutral forum to discuss a wide range of topics related to Nickel Allergic Contact Dermatitis (NACD) and the EU Nickel Restriction. The objective was to provide an open platform to share views, experiences and concerns as well as discuss the achievements and challenges ahead, 20 years after the adoption of the EU Nickel Directive.

The event provided an update on the latest EU activities relevant to the implementation of the Nickel Restriction, shared up-to-date knowledge on NACD and created a forum for cooperative and constructive communication between stakeholders regarding their practical experiences, challenges, concerns, expectations, current EU developments and potential implications as well as introduce a new scientific research project being conducted by the Nickel Institute.

Download the summary report . Presentations and further information can be found here.

Nickel allergic contact dermatitis is an immune reaction (type 4 delayed reaction) to solubilized nickel ions that have entered the skin. Individuals with nickel skin sensitisation experience a skin reaction, usually inflammation and itching, when they come in direct and prolonged contact with items releasing a sufficient amount of solubilized nickel.

Individuals can become sensitised to nickel through direct and prolonged contact to items such as some types of jewelry, piercings or nickel-coated clothes fastenings (like buckles, zippers and clasps), if these release an amount of solubilised nickel sufficient to cause nickel sensitisation. Once an individual has become nickel-sensitised, direct and prolonged exposure to items releasing significant nickel (but can be less than the amount that caused the initial sensitisation reaction) can cause a skin allergic reaction known as nickel allergic contact dermatitis.

A common cause of nickel sensitisation is piercings (both earrings and body piercings) if the material used in the piercings release sufficient amounts of nickel. Other causes of nickel sensitisation are direct and prolonged contact with other types of jewelry and clothing fasteners which release a sufficient amount of solubilized nickel to cause a nickel sensitization.

Research is not conclusive at this point but it is thought that this may be due to the fact that women wear more jewelry and have more piercings than men. A smaller portion of these are affected by NACD, depending on their level of sensitivity and exposures to nickel-releasing items.

The symptoms of an allergic reaction to nickel can include skin dryness, chapping, eczema, blisters and inflammation at the site of the exposure to items releasing a sufficient amount of solubilized nickel. To be sure that the symptoms are caused by an allergy and to determine the cause of the allergy, a dermatologist should be consulted. A review of exposures and clinical history should be conducted, possibly accompanied by a skin allergy test to confirm whether the allergen is nickel if the exposures and reactions are consistent with nickel allergic contact dermatitis.

The most effective approach to prevent NACD is for nickel-sensitised individuals to avoid direct and prolonged contact with high nickel-releasing items, particularly jewelry and clothing fasteners made of high nickel-releasing materials. Selecting items labeled as surgical stainless steel, as a low nickel-releasing material considered to be safe for direct and prolonged contact applications, can prevent NACD.

Handling coins is not thought to cause nickel sensitisation. Research has shown that nickel-sensitised individuals handling nickel-containing coins for eight hours per day for 10 days did not experience an allergic reaction. Also, a 1999 risk assessment from the Danish government's Environmental Protection Agency shows that there is no significant risk from handling coins for the general public. Billions of people have been handling billions of nickel-containing coins for over a century without a significant number of adverse effects.

Even in sensitised individuals, transient and brief contact with nickel-containing items like coins, keys, handles, tools etc. is not likely to cause an allergic reaction. Specifically for coins, there are no reports of a significant number of adverse effects in Canada or the United States where many nickel-releasing coins are used. Interestingly, in Canada where the 5, 10 and 25 cents coins have been made of pure nickel for many decades, there are no reports of a significant number of adverse effects. In the US, where the 25 cent coin (also known as a quarter) is low nickel-releasing with normal use as brief contact (but can release high amounts of nickel with prolonged contact), there is no evidence of significant adverse dermatological effects.

Some foods naturally contain nickel, including nuts, chocolate and beans. Eating these foods does not cause an allergic contact dermatitis reaction except in a very small portion of the population that is extremely nickel-sensitive (i.e. who react to very low levels of nickel). Oral exposure to nickel-containing items is not thought to cause nickel-sensitisation in non-nickel sensitised individuals.

In the European Union, there is legislation that limits the nickel release rate from nickel objects if they are intended to be in direct and prolonged contact with the skin, e.g. in earrings, piercings, other jewelry or clothes fasteners. If the EU's nickel release legislation were properly enforced, dermatologists believe nickel allergic contact dermatitis and eventually nickel sensitisation (the number of already nickel-sensitised individuals) would fall to very low levels. There is already evidence of lower prevalence of nickel sensitisation in younger populations.

The average threshold for nickel NACD is correlated with a nickel release rate from an article of 0,5 µg/cm²/week. This was derived by comparing nickel release rates of different materials with patch test reactions of nickel-sensitised individuals to those same materials.

The European Union standardized nickel release test (EN1811) measures how much of the nickel, once corroded, can be available to the skin to be absorbed and cause a nickel allergic dermatitis reaction. This would be the potential amount of dermal exposure. Nickel within the article must first be corroded, which requires direct and prolonged contact with a medium such as sweat. The corrosion product must then be dissolved into nickel ions that can be absorbed through the skin to cause a nickel allergic reaction, since nickel particles do not pass through the skin or cause a reaction on their own.

It is therefore the nickel release, not the content of nickel in the material that is important. Some nickel-containing materials release very little nickel, if any, such as some stainless steels that are very corrosion resistant (e.g., surgical stainless steel). This is why these stainless steels are used for many applications.

No. Nickel allergy cannot cause anaphylaxis. This is because it is a Type 4 "delayed reaction allergy". Unlike some other allergens (Type 1,2 and 3) nickel allergy is not life-threatening and cannot trigger anaphylactic shock.

To trigger NACD three simultaneous conditions must occur. 1. Direct skin contact with the nickel-releasing item, 2. Prolonged skin contact with the nickel-releasing item, 3. A sufficient amount of nickel must be released and absorbed into the skin to cause a NACD reaction.